Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM

K-Number: K112987 · 2011-12-16

ApplicantBiolitec Medical Devices, Inc.
Decision Date2011-12-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biolitec Medical Devices, Inc.. It received FDA 510(k) clearance on 2011-12-16 under 510(k) number K112987. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM?

TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2011-12-16. The listed applicant is Biolitec Medical Devices, Inc.. The 510(k) number is K112987.

When did TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM receive FDA 510(k) clearance?

TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM received FDA 510(k) clearance on 2011-12-16, under 510(k) number K112987.

Who is the listed applicant for TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM?

The FDA 510(k) record lists Biolitec Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM?

The FDA product code for TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biolitec Medical Devices, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120231EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)K113688MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEMK113858MEGABEAM ENDO-ENT PROBEK113709MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECEK113792MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBEK112299ENDOVASCULAR LASER VEIN SYSTEM KIT

View all 9 devices →

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑